Apparatus and method for intragastric balloon with in situ adjustment means

ABSTRACT

An intragastric balloon and method of adding and/or removing fluid therefrom are disclosed. The intragastric balloon includes a shell, a grasping tab, and a selfsealing portion. A gastroscopic instrument which includes a grasping tool is inserted into the stomach of a patient and used to grasp the grasping tab located on the surface of the shell. Using the grasping tool, the intragastric balloon is securely fastened to the gastroscopic instrument. A filling instrument, such as a needle, is advanced through the self-sealing portion of the shell for the filling or deflating of the intragastric balloon. After inflation or deflation is complete, the filling instrument is then withdrawn from the balloon and the gastroscopic instrument withdrawn from the stomach.

RELATED APPLICATION

This application claims is a divisional of U.S. patent application Ser.No. 11/540,177, filed Sep. 29, 2006, which is incorporated herein byreference.

BACKGROUND OF INVENTION

1. Field of the Invention

The present invention is directed to devices and methods that enableinflatable intragastric balloons used for the treatment of obesity to befilled, and in particular to devices and methods that enable theintragastric balloon to be filled, adjusted, or deflated while thedevice itself is in the stomach.

2. Description of the Related Art

Intragastric balloons are well known in the art as a means for weightloss and treating obesity. One such inflatable intragastric balloon isdescribed in U.S. Pat. No. 5,084,061 and is commercially available asthe BioEnterics Intragastric Balloon System (sold under the trademarkBIB®). These devices are designed to provide therapy for moderatelyobese individuals who need to shed pounds in preparation for surgery, oras part of a dietary or behavioral modification program.

The BIB® System, for example, consists of a silicone elastomerintragastric balloon that is inserted into the stomach and filled withfluid. Commercially available gastric balloons are filled with salinesolution or air. The intragastric balloon functions by filling thestomach and enhancing appetite control. Placement of the intragastricballoon is non-surgical, usually requiring no more than 20-30 minutes.The procedure is performed gastroscopically in an outpatient setting,typically using local anesthesia and sedation. Placement is temporary,and intragastric balloons are typically removed after six months.

Most intragastric balloons utilized for this purpose are placed in thestomach in an empty or deflated state and thereafter filled (fully orpartially) with a suitable fluid through a filler tube. The filler tubecan be either removable or permanently attached to the balloon. Theremovable filler tube is typically attached prior to initial placementof the gastric balloon and then removed after inflation. The balloonoccupies space in the stomach, thereby leaving less room available forfood and creating a feeling of satiety for the overweight patient.Clinical results with these devices show that for many overweightpatients, the intragastric balloons significantly help to controlappetite and accomplish weight loss.

Among the intragastric balloons described in the prior art, one typeremains connected to a filler tube during the entire period the balloonresides in the stomach. The balloon is introduced into the patient'sstomach and a connected tube is extended through the nostril. Such anintragastric balloon is described, for example, in U.S. Pat. No.4,133,315.

Another type of prior art intragastric balloon is placed into thestomach with the assistance of an appropriate phistic tube and usually astylette. The balloon is filled with saline, whereafter the tube andstylette are withdrawn from the stomach. An intragastric balloon of thissecond type is described, for example, in UK Patent Application GB 2 090747.

Even for the balloons of the second type, it may become desirable, fromtime-to-time, to add more fluid in order to further expand the balloonto optimize weight control. In addition, one means of removing theballoon is to deflate it by removing the saline from the balloon througha tube before the empty balloon is removed from the stomach.

To accomplish the foregoing, intragastric balloons of the second typeare normally equipped with a self-sealing valve into which the fillertube and/or stylette can be inserted. One difficulty frequentlyencountered with this type of intragastric balloon is locating the valvewhen the balloon is already in the stomach and the surgeon attempts toreinsert the filler tube for the purpose of adding or removing fluidfrom the balloon.

Those skilled in the art will readily appreciate that manipulating theballoon while in situ to visually locate the valve is rather difficult,and the process of searching for the valve undesirably prolongs theprocedure. Those experienced in the art will also readily appreciatethat some intragastric balloons have been equipped with tabs forgrasping the balloon for physical manipulation within the stomach and/orremoval. For example, such tabs are shown in U.S. Pat. Nos. 5,084,061and 6,746,460.

Even with the incorporation of such tabs into current intragastricballoon designs, the surgeon may still encounter significant difficultyin finding the valve for filling or removing fluid from the balloon. Andeven after the valve has been visually located, it is often stilldifficult or awkward for the surgeon to reinsert the filler tube intothe example valve. The balloon may be slippery and positionallyunstable. Additionally, spherical (or substantially spherical)intragastric balloons readily rotate in the stomach, so that even aslight disturbance of the balloon may place the filler valve intovirtually any possible position relative to the filler tube poised toengage it.

Another problem associated with the heretofore known methods and devicesis that following placement of the intragastric balloon, a patient mayexperience nausea from the interaction of the recently placed gastricballoon within the stomach. This has been particularly noted when theintragastric balloon is placed and filled to its capacity orsubstantially to its capacity in a single procedure.

Therefore, the present invention is directed at overcoming theseproblems associated with the prior art systems. These and othercharacteristics of the present invention will become apparent from thefurther disclosure to be made in the detailed description given below.

SUMMARY

The present invention addresses the above-described problems byproviding an apparatus and method for adjusting an inflatableintragastric balloon in situ. In contrast to the prior art devicesdescribed above, the inflatable intragastric balloon of the presentinvention has a grasping button or tab which allows the surgeon tocapture and securely hold the intragastric balloon using a specializedgastroscopic instrument. The gastroscopic instrument also includes afilling instrument for adjusting the volume of fluid contained withinthe balloon.

More particularly, an intragastric balloon is provided with a combinedgrasping button/valve assembly. The surgeon deploys a gastroscopicinstrument into a patient's stomach, for example, to capture and holdthe intragastric balloon. The tip of the gastroscopic instrument isequipped with a grasping tool that securely fastens to the buttonportion of the button/valve assembly. Once the intragastric balloon issecurely fastened to the instrument, a filling instrument is deployedthrough a self-sealing valve contained within the button/valve assembly.Once the filling instrument is deployed into the balloon, the surgeonmay then add or remove a desired amount of fluid to adjust the size ofthe balloon to a desired volume. In this way, the surgeon is able toquickly adjust the volume of the balloon in a minimally invasivefashion, without requiring removal and re-implantation, or completereplacement of the balloon. In addition, the apparatus and method of thepresent invention significantly eliminates the difficulties in prior artdevices of capturing and securely holding in situ an intragastricballoon.

According to another aspect of the invention, an intragastric balloon isprovided that has a self-sealing surface portion and a grasping tab forsecurely fastening the gastroscopic instrument to the balloon. In thisaspect, the self-sealing portion encompasses a portion or severalportions of the surface of the balloon and allows for the surgeon to beless targeted in the deployment of a filling instrument, such as aneedle. As described above, the surgeon deploys the gastroscopicinstrument into the stomach and uses the grasping tool to capture one ofthe grasping tabs located on the surface of the balloon. The surgeon maythen advance the filling instrument through one of the self-sealingsurface portions of the balloon. Once fully advanced, the surgeon mayadjust the volume of the balloon using the filling instrument. In thisaspect, because the balloon has one or more self-sealing surfaces and/orgrasping tabs, the surgeon has a number of locations to grasp theballoon and/or adjust its volume.

In addition to the aspects of the invention discussed above, the shapeof the intragastric balloon of the present invention may be altered tothat of a dual hemisphere, or other similar configuration. This allowsfor easier grasping of the intragastric balloon of the presentinvention.

In yet another aspect of the present invention, the intragastric balloonshell has a magnet embedded within the balloon shell or on the shell'ssurface. A corresponding magnetic surface is located on the tip of thegastroscopic instrument, which allows the surgeon to capture the balloonusing magnetic force. This is yet another aspect of the presentinvention that significantly reduces the difficulties associated withthe prior art.

In still another aspect of the present invention, an intragastricballoon has a recess that allows a surgeon to more easily position aneedle or other instrument for filling and/or removing fluid from theballoon without the use of a grasping tool for capturing the balloon.The surgeon guides a needle or other filling-type instrument towards theconically-shaped recess, which has a valve or self-sealing portionlocated at the bottom of the recess. Several valve or self-sealingsurface configurations may be implemented in this embodiment and locatedat the bottom of recess for filling or deflating of the balloon. Theseand various other aspects of the invention, and its advantages, will bediscussed in more detail below.

Because of its in situ adjustability, the balloon can be filled over theduration of its placement, if desired, to improve weight loss over time.If weight loss is slow, the surgeon can add volume to the device to takeup greater space in the stomach and encourage early satiety. With theimproved weight loss over time, the device would benefit from a longerplacement time while having a variable fill volume. To improve theduration of adjustability, the shell is preferably made from a highlyacid resistant material such as diphenyl silicone,polytetrafluoroethylene (PTFE), modified PTFE, silicon-polyurethaneelastomers, high density polyethylene (HOPE), low density polyethylene(LDPE) or other acid resistant shell materials. The shell may also becoated with a coating such as parylene to improve the acid resistance ofdevice.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of an intragastric balloon according to oneembodiment of the present invention, which includes a combined graspingbutton/valve assembly.

FIG. 2 is a side view of the intragastric balloon shown in FIG. 1.

FIG. 3 is an elevated side view of the intragastric balloon shown inFIG. 1.

FIG. 4 is a side view of the grasping button/valve assembly of theintragastric balloon shown in FIG. 1.

FIG. 5 is an elevated side view of the grasping button/valve assembly ofthe intragastric balloon shown in FIG. 1.

FIG. 6 is an elevated side view of a gastroscopic balloon adjustmentinstrument according to another embodiment of the present invention.

FIG. 7 is a close up view of the tip of the gastroscopic balloonadjustment instrument shown in FIG. 6.

FIG. 8 is an elevated side view of an intragastric balloon according toanother embodiment of the present invention, which includes aself-sealing shell portion and a loop tab for grasping.

FIG. 9 is an elevated side view of an intragastric balloon according toyet another embodiment of the present invention, which includes aself-sealing shell portion with a loop tab incorporated on its surface.

FIG. 10 is an elevated side view of an intragastric balloon according toyet another embodiment of the present invention, which includes severalself-sealing shell portions and several grasping tabs.

FIG. 11 is a side view of an intragastric balloon according to yetanother embodiment of the present invention, which includes two balloonhemisphere portions and a connecting portion with a self-sealingsurface.

FIG. 12 is an elevated side view of an intragastric balloon according toyet another embodiment of the present invention, which includes aconical recess for receiving a gastroscopic instrument.

FIG. 13 is an elevated side view of an intragastric balloon according toyet another embodiment of the present invention, which includes alocating magnet on a self-sealing portion.

FIG. 14 is a close up view of a magnetic-tipped gastroscopic balloonadjustment instrument according to another embodiment of the presentinvention.

FIG. 15 is an elevated side of the grasping button/valve assembly of theintragastric balloon of FIGS. 1-3 being captured by the gastroscopicballoon adjustment instrument of FIGS. 6-7.

DETAILED DESCRIPTION

The present invention is directed to a device and method for adjustingintragastric balloon volume in vivo or in situ, thereby avoiding theneed to remove the balloon from the stomach.

Referring to FIGS. 1-3, an intragastric balloon according to onepreferred embodiment of the present invention is shown. The intragastricballoon 10 includes a shell 12 and a grasping button/valve assembly 14.

A method of adding or removing fluid, such as saline, from theintragastric balloon 10 according to the present invention requires thatan intragastric balloon be implanted in a patient. During implantation,an uninflated balloon 10 may be positioned in the stomach in a desiredlocation. A gastroscopic instrument, such as that shown in FIGS. 6-7 maybe used to grasp the grasping button/valve assembly 14. FIGS. 4 & 5 showa close up view of the grasping button/valve assembly 14, which isintegrated with the balloon shell 12. While the grasping tab of FIGS.1-5 is a button configuration, those skilled in the art will appreciatethat the tab may be in any number of configurations that may besubstituted without departing from the scope of the invention. Forinstance, several loop configurations for the grasping tab are disclosedin FIGS. 8-10.

As can be seen in the close up view of FIG. 7, the instrument 50includes a grasping tool 52 and needle 54. The surgeon performs the insitu adjustment as follows. The surgeon manipulates the gastroscopicinstrument of FIGS. 6-7 to capture the grasping button/valve assembly 14shown in FIGS. 1-5. For example, as shown in FIGS. 1-4, the graspingbutton/valve assembly 14 includes a relatively wide proximal flange 14 ainterfacing an outer surface of the shell 12, and a relatively narrowdistal flange 14 b spaced apart from proximal flange 14 a. The buttonridge 20 is disposed between the proximal flange 14 a and the distalflange 14 b. Grasping button/valve assembly 14 further includes adepending portion 14 d located in interior space of the shell cavity asshown. As shown most clearly in FIG. 5, the septum 22 is surrounded bydistal flange 14 b. Using the gastroscopic instrument, the surgeonpositions grasping tool 52 in its “open” position to securely capturethe grasping button/valve assembly 14 around the button ridge 20 suchthat the tool 52 is secured at button ridge 20 between proximal flange14 a and distal flange 14 b, as shown in FIG. 15. The surgeon may thenactuate the instrument 50 such that grasping tool 52 securely fastens tothe balloon 10 by tightening the grasping tool around the button ridge20. With the balloon securely fastened to the instrument, the surgeonmay then advance the needle 54 of instrument 50 to pass through valve22. FIG. 15 shows grasping tool 52 securely fastened around button ridge20, with needle 54 advanced through valve 22. Valve 22 may be of aself-sealing septum type, comprised of a compressed silicone disc orother suitable material. Alternately, valve 22 may be a self-sealingleaf valve, slit valve, or the like. With the needle advanced throughvalve 22, the surgeon may then add the desired amount of fluid into theballoon. In the alternative, should the surgeon wish to remove a desiredamount of fluid from the balloon, the surgeon may follow the same stepsexcept use the needle to withdraw the desired amount of fluid.

Once a sufficient volume of fluid is added to or removed from theintragastric balloon, the surgeon retracts the needle back into thegastroscopic instrument. The grasping tool is then released from thegrasping button. The gastroscopic instrument may then be removed fromthe patient, thus allowing for the procedure to be minimally invasive.

As an alternative to the self-sealing valve 22, the valve of the presentinvention may be of a “Two Way Slit Valve” type described in thecommonly assigned international application published as WO 20051007231,the disclosure of which is incorporated herein by reference. Inaddition, in the alternative to the needle 54 of the instrumentdescribed above, the gastroscopic instrument may have a filler tube withan injection tip of the type described in the above mentionedinternational application. In addition to the grasping button/valveassembly 14 described above for in situ adjustment of the balloonvolume, balloon 10 may also include an additional quick-fill valve foruse during the initial placement and filling of the balloon.

FIGS. 8-10 show an intragastric balloon according to another embodimentof the present invention. Referring to FIG. 8, the intragastric balloon10 includes a shell 12 and a grasping tab, such as a loop tab 24. Theshell has a self-sealing shell portion 26 in place of the valvepreviously described. Similar to the first embodiment described above,using a gastroscopic instrument, the surgeon positions the grasping tool52 in its “open” position to securely capture the grasping tab 24. Thetip of the gastroscopic instrument 50 may be altered such that a hook oropen ended loop may be used for grasping tool 52 in order to more easilycapture loop tab 24. The surgeon may then actuate the instrument 50 suchthat grasping tool 52 securely fastens to the balloon 10 by tighteningthe grasping tool around grasping tab 24. A portion of the shell has aselfsealing surface 26. With the balloon securely fastened to theinstrument, the surgeon may then advance the needle 54 of instrument 50to pass through self-sealing surface 26. Balloon 10 may include visualmarkers 29, as shown in FIG. 8, to allow the surgeon to visually confirmthe proper placement of the needle on the shell before piercing theself-sealing portion using the gastroscopic instrument. With the needleadvanced through self-sealing surface 26, the surgeon may either fill ordeflate the balloon as discussed above.

Self-sealing surface 26 may be comprised of a thicker tear resistantmaterial, such as silicone or elastomer. Alternatively, the innersurface of self-sealing surface 26 could include gel or foam liners,such as silicones, hydro gels or elastomers, to seal in the area fromthe various needle punctures. Alternatively, any of these self-sealingmeans may be added to the entire shell 12 rather than just a portion 26thereof to allow for easy puncturing with minimal need for manipulatingthe balloon to target a specific location.

FIGS. 9 & 10 illustrate further embodiments of the intragastric balloonof the present invention. FIG. 9 shows balloon 10, with shell 12, andself-sealing surface 26, whereby loop tab 24 is located centrally onself-sealing surface 26, thus allowing ease of locating, grasping, andinsertion of needle 54. FIG. 10 shows balloon 10, shell 12, a pluralityof self-sealing surfaces 26, and loop tabs 24. In this embodiment,multiple loop tabs and multiple self-sealing surfaces provide severaloptions for the surgeon to properly position needle 54. In theembodiment of FIG. 10, the multiple self-sealing surfaces may each havea centrally located loop tab, as shown in the embodiment of FIG. 9.

In addition to the embodiments discussed above that include aself-sealing valve or surface, the entire shell may be comprised of apuncture-able, self-sealing shell. By adding hydrophilic materials tothe inner lining of the balloon or adding the hydrophilic material intothe shell in order to swell the shell, the full shell may beself-sealing. In addition, any of the methods discussed above forcreating a self-sealing portion of the shell may be applied to theentire shell such that the entire shell becomes self-sealing. In thisway, the balloon adjustment may be performed with just a gastroscopicneedle, and a grasping tab is not needed to capture the balloon foradjustment. In this embodiment, the physician may puncture any portionof the balloon.

FIG. 11 shows a further embodiment of the present invention.Intragastric balloon 10 includes a first hemisphere shell portion 32, asecond hemisphere shell portion 34, and a connecting portion 36.Connecting portion 36 is self-sealing and connects the two hemisphereportions 32 and 34. In adjusting the gastroscopic balloon of FIG. 11, agastroscopic instrument similar to that shown in FIGS. 6 & 7 may beused. Using the gastroscopic instrument, the surgeon would position thegrasping tool 52 in its “open” position to securely capture the balloon10. Grasping tool 52 may open to a large enough circumference to allowit to fit over one of the hemispheres in its entirety. Grasping tool 52may then be positioned such that it is centered over connecting portion36. The surgeon may then actuate the instrument 50 such that graspingtool 52 securely fastens to the balloon 10 by tightening the graspingtool around connecting portion 36. With the balloon securely fastened tothe instrument, the surgeon may then advance the needle 54 of instrument50 to pass through self-sealing surface 38. Self-sealing surface 38 mayrun the entire circumference of the connecting portion 36. In this way,properly securing the gastroscopic instrument 50 to the connectingportion ensures that the needle 54 will pass through the self-sealingsurface 38. With the needle advanced through self-sealing surface 38,the surgeon may either fill or deflate the balloon as discussed above.

FIG. 12 shows a further embodiment of the present invention.Intragastric balloon 10 includes a frustaconical recess 30. Recess 30allows the surgeon to more easily position a needle or other instrumentfor filling and/or removing fluid from the balloon without the use of agrasping tool for capturing the balloon. The surgeon guides a needle orother filling-type instrument towards the recess. Conical recess 30 hasconically shaped walls 31 that guide the needle or other fillinginstrument to a valve or self-sealing portion located at the bottom ofthe recess as the instrument is advanced into recess 30. Any of thevalve or self-sealing surface configurations discussed above may beimplemented in this embodiment and located at the bottom of recess 30for filling or deflating of the balloon.

FIG. 13 shows still yet a further embodiment of the present invention.Intragastric balloon 10 has self-sealing portion 26 and magnet 35. FIG.14 shows a close-up of the tip of a magnetic gastroscopic instrumentused in conjunction with this balloon embodiment. Gastroscopicinstrument 50 may be equipped with a magnet 56. As the surgeon advancesthe gastroscopic instrument 50 towards the balloon 10 in the stomach,magnet 35 of balloon 10 is attracted to magnet 56 of instrument 50, andin this way the surgeon is able to capture the balloon with theinstrument. Once the balloon has been captured by the magneticattraction between magnet 56 of instrument 50 and magnet 35 of balloon10, the surgeon may advance needle 54 through self-sealing portion 26,and the surgeon may either fill or deflate the balloon as discussedabove. The magnet may be placed in any number of desired locations,including on the inside or outside surface of the balloon or on theself-sealing portion itself. Alternatively, the magnet may be embeddedin the balloon or self-sealing material.

EXAMPLES

The following examples, describing various procedures using the devicesand methods of the present invention, are for illustrative purposes onlyand are not intended, nor should they be interpreted, to limit the scopeof the invention.

Example 1 In Vivo Adjustment of a Balloon with a Button/Valve Assembly

In this example, the surgeon performs an in vivo adjustment of anintragastric balloon that has been previously implanted in a patient. Inthis example, the surgeon wishes to add more fluid to a previouslyimplanted intragastric balloon that includes a grasping button/valveassembly, such as that shown in FIGS. 4 & 5. The gastroscopic instrumentof this example is equipped with a camera, a needle for adding fluid,and a grasping tool for capturing the button of the button/valveassembly located on the surface of the intragastric balloon.

The patient is anesthetized, and the surgeon begins the procedure byinserting a gastroscopic instrument into the stomach. Using a cameralocated on a specially configured gastroscopic instrument, such as thatshown in FIGS. 6 & 7, the surgeon maneuvers the gastroscopic instrumentinto position to grasp the grasping button/valve assembly. The surgeonpositions grasping tool 52 (FIG. 7) in its “open” position” around thebutton/valve assembly.

The surgeon then actuates the instrument 50 such that grasping tool 52securely fastens to the balloon 10 by tightening the grasping toolaround the button ridge 20. With the balloon securely fastened to theinstrument, the surgeon advances the needle 54 of instrument 50 to passthrough valve 22 (FIG. 15 shows the grasping tool securely fastened tothe intragastric balloon).

With the needle advanced through valve 22, the surgeon adds the desiredamount of fluid into the balloon.

Once a sufficient volume of fluid is added to the intragastric balloon,the surgeon retracts the needle back into the gastroscopic instrument.The grasping tool is then released from the grasping button. Thegastroscopic instrument is then removed from the patient.

Example 2 In Vivo Adjustment of a Balloon with Self-Sealing Shell

In this example, the surgeon performs an in vivo adjustment of anintragastric balloon that has been previously implanted in a patient. Inthis example, the surgeon wishes to add more fluid to a previouslyimplanted intragastric balloon that includes a self-sealing portion,such as that shown in FIG. 9, wherein a grasping tab is located on theself-sealing portion. The gastroscopic instrument of this example isequipped with a camera, a needle for adding fluid, and a grasping toolfor capturing the grasping tab located on the surface of theintragastric balloon.

The patient is anesthetized, and the surgeon begins the procedure byinserting a gastroscopic instrument into the stomach. Using the cameralocated on a specially configured gastroscopic instrument, such as thatshown in FIGS. 6 & 7, the surgeon maneuvers the gastroscopic instrumentinto position to grasp the grasping tab 24. The surgeon positions thegrasping tool of the gastroscopic instrument in its “open” position” tograsp grasping tab 24.

The surgeon then actuates the instrument 50 such that grasping toolsecurely fastens to the balloon 10 by tightening the grasping toolaround the grasping tab. With the balloon securely fastened to theinstrument, the surgeon advances the needle 54 of instrument 50 to passthrough valve 22 (FIG. 15 shows the grasping tool securely fastened tothe intragastric balloon).

With the needle advanced through valve 22, the surgeon adds the desiredamount of fluid into the balloon.

Once a sufficient volume of fluid is added to the intragastric balloon,the surgeon retracts the needle back into the gastroscopic instrument.The grasping tool is then released from the grasping button. Thegastroscopic instrument is then removed from the patient.

Example 3 In Vivo Adjustment of a Balloon with Dual-HemisphereConfiguration

In this example, the surgeon performs an in vivo adjustment of anintragastric balloon that has been previously implanted in a patient. Inthis example, the surgeon wishes to add more fluid to a previouslyimplanted intragastric balloon that is of a dual hemisphereconfiguration, such as that shown in FIG. 11. The gastroscopicinstrument of this example is equipped with a camera, a needle foradding fluid, and a grasping tool for capturing the intragastricballoon.

The patient is anesthetized and the surgeon begins the procedure byinserting a gastroscopic instrument into the stomach. Using the cameralocated on a specially configured gastroscopic instrument, such as thatshown in FIGS. 6 & 7, the surgeon maneuvers the gastroscopic instrumentinto position to fit over one of the hemispheres of the balloon. Thesurgeon positions the grasping tool of the gastroscopic instrument inits “open” position”. The physician then positions grasping tool 52 suchthat it is centered over connecting portion 36 (FIG. 11).

The surgeon then actuates the instrument 50 such that grasping tool 52securely fastens to the balloon 10 by tightening the grasping toolaround connecting portion 36. With the balloon securely fastened to theinstrument, the surgeon advances the needle 54 of instrument 50 to passthrough self-sealing surface 38 of the connecting portion, which in thisexample runs the entire circumference of the connecting portion.

With the needle advanced through self-sealing surface 38, the surgeonadds the desired amount of fluid into the balloon.

Once a sufficient volume of fluid is added to the intragastric balloon,the surgeon retracts the needle back into the gastroscopic instrument.The grasping tool is then opened and removed from the hemisphere of theballoon. The gastroscopic instrument is then removed from the patient.

Example 4 In Vivo Adjustment of a Balloon with a Recess

In this example, the surgeon performs an in vivo adjustment of anintragastric balloon that has been previously implanted in a patient. Inthis example, the surgeon wishes to add more fluid to a previouslyimplanted intragastric balloon of the type shown in FIG. 12, whichincludes a recess for accepting the gastroscopic instrument. The bottomof the recess in this example has a self-sealing portion for accepting aneedle for filling the balloon. The gastroscopic instrument of thisexample is equipped with a camera, a needle for adding fluid, and aslightly pointed tip for guiding the instrument into the recess.

The patient is anesthetized and the surgeon begins the procedure byinserting a gastroscopic instrument into the stomach. Using the cameralocated on a specially configured gastroscopic instrument, such as thatshown in FIGS. 6 & 7, the surgeon maneuvers the gastroscopic instrumentinto position to place the tip instrument into the recess.

With the gastroscopic instrument properly positioned in the recess, thesurgeon advances the instrument so that it reaches the bottom of therecess on the surface of the intragastric balloon. Once the gastroscopicinstrument reaches the bottom, reaches the bottom of the recess, thesurgeon advances the needle 54 of instrument 50 to pass throughself-sealing surface located at the bottom of the recess.

With the needle advanced through self-sealing surface, the surgeon addsthe desired amount of fluid into the balloon.

Once a sufficient volume of fluid is added to the intragastric balloon,the surgeon retracts the needle back into the gastroscopic instrument.The gastroscopic instrument is then removed from the patient.

Example 5 In Vivo Adjustment of a Balloon with a Magnet

In this example, the surgeon performs an in vivo adjustment of anintragastric balloon that has been previously implanted in a patient. Inthis example, the surgeon wishes to add more fluid to a previouslyimplanted intragastric balloon that is of the type shown in FIG. 13,which includes a magnet located in a self-sealing portion for use inconjunction with the gastroscopic instrument. The gastroscopicinstrument of this example is equipped with a camera, a needle foradding fluid, and a magnetic tip for capturing the magnet embedded inthe self-sealing portion of the balloon.

The patient is anesthetized and the surgeon begins the procedure byinserting a gastroscopic instrument into the stomach. Using the cameralocated on a specially configured gastroscopic instrument, such as thatshown in FIGS. 6 & 7, the surgeon maneuvers the gastroscopic instrumentinto position to place the tip instrument in contact with the portion ofthe self-sealing portion of the balloon that contains the embeddedmagnet.

With the gastroscopic instrument properly positioned above the magnet inthe balloon, the surgeon advances the instrument so that it comes incontact with the magnet located in the balloon and captures the magnet.With the balloon captured by the gastroscopic instrument, the surgeonadvances the needle 54 of instrument 50 to pass through self-sealingsurface of the balloon.

With the needle advanced through self-sealing surface, the surgeon addsthe desired amount of fluid into the balloon.

Once a sufficient volume of fluid is added to the intragastric balloon,the surgeon retracts the needle back into the gastroscopic instrument.The gastroscopic instrument is then removed from the patient.

Although the invention has been particularly shown and described withreference to certain preferred embodiments, it will be readilyappreciated by those of ordinary skill in the art that various changesand modifications may be made in the invention and specific examplesprovided herein without departing from the spirit and scope of theinvention.

I claim:
 1. A method of adjusting the volume of an implantedintragastric balloon comprising the steps of: inserting a gastroscopicinstrument into the stomach of a patient having an intragastric balloonimplanted therein; grasping the balloon using a specially-adaptedgastroscopic instrument to grasp and capture the intragastric balloon;advancing a filling instrument into a self-sealing portion located on asurface of the intragastric balloon; adding fluid to or removing fluidfrom the intragastric balloon via the filling instrument; withdrawingthe filling instrument from the balloon; and withdrawing thegastroscopic instrument from the stomach.
 2. The method of claim 1,wherein the self-sealing portion is a septum.
 3. The method of claim 1,wherein the self-sealing portion is a self-sealing surface.
 4. Themethod of claim 1, wherein the self-sealing portion is a slit valve. 5.The method of claim 1, wherein the self-sealing portion is aself-sealing surface of the intragastric balloon.
 6. The method of claim1, wherein the filling instrument is a needle.
 7. The method of claim 1,wherein the implanted intragastric balloon has a grasping tab located onits surface for capturing the balloon.
 8. The method of claim 7, whereinthe specially-adapted gastroscopic instrument has a grasping tool forcapturing the grasping tab.
 9. The method of claim 1, wherein theimplanted intragastric balloon has a plurality of inflatable portionsconnected by at least one connecting portion having a self-sealingsurface.
 10. The method of claim 9, wherein the specially-adaptedgastroscopic instrument has a grasping tool for capturing at least oneof the inflatable portions.
 11. The method of claim 1, wherein thesurface of the balloon further comprises a magnet.
 12. The method ofclaim 11, wherein the specially-adapted gastroscopic instrument has amagnet for capturing the magnet of the surface of the balloon.
 13. Themethod of claim 1, wherein the surface of the balloon further comprisesa recess for accepting the specially-adapted gastroscopic instrument.14. The method of claim 13, wherein the specially-adapted gastroscopicinstrument is configured to fit into the recess.
 15. The method of claim1, wherein the intragastric balloon comprises at least one of diphenylsilicone, PTFE, silicone-polyurethane elastomer, HDPE, LDPE or parylene.